# Denterprise International, Inc.

- Location (FDA's records): Ormond Beach, FL
- FDA decisions: 4 (2012–2023): 4 510(k) clearances
- Product codes: MUH (2), EHD (2)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 10 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012): 1 (https://510kreport.com/company/digimed-co-digimed-until-31-12-2012)
- Owandy: 1 (https://510kreport.com/company/owandy)
- Edlen Imaging, LLC: 1 (https://510kreport.com/company/edlen-imaging)

## Firms that cite its devices most
- Ningbo Runyes Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/ningbo-runyes-medical-instrument)
- Sodium Systems, LLC: 1 (https://510kreport.com/company/sodium-systems)
- Athlos OY: 1 (https://510kreport.com/company/athlos)
- Radiotecnologia Industrial S.A. DE C.V.: 1 (https://510kreport.com/company/radiotecnologia-industrial)
- Fona S.R.L: 1 (https://510kreport.com/company/fona)
- Remedi Co., Ltd.: 1 (https://510kreport.com/company/remedi)
- Changzhou Sifary Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/changzhou-sifary-medical-technology)
- Trident S.R.L: 1 (https://510kreport.com/company/trident)

## Its most-cited devices
- K151926: QuickRay HD Intraoral Sensor (2015), cited by 7
- K180561: MobileX Portable X-ray System (2018), cited by 2
- K122582: Dental X-Ray Z70 (W); Dental X-Ray Z70 (M); Dental X-Ray Z70 (C) (2012), cited by 1

## Recent decisions
- K231202: QuickRayPRO (Jun 22, 2023)
- K180561: MobileX Portable X-ray System (Apr 4, 2018)
- K151926: QuickRay HD Intraoral Sensor (Dec 14, 2015)
- K122582: Dental X-Ray Z70 (W); Dental X-Ray Z70 (M); Dental X-Ray Z70 (C) (Dec 7, 2012)

Source page: https://510kreport.com/company/denterprise-international